Argus Screen Shots General Tab - Katalyst HLS
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This document provides guidelines for entering and managing case reports within Argus Safety, covering key aspects such as report types, data fields, and processing workflow. It details how to categorize cases, manage reporter information, and the importance of confidentiality, particularly for consumer reports. Additionally, it outlines specific procedures for handling cases from license partners and other companies.
Argus Screen Shots General Tab - Katalyst HLS
- 1. 01/29/17Katalyst Healthcares & Life Sciences 1 ARGUS Screen SHOTS General Tab
- 2. GENERAL SCREENGENERAL SCREEN Entering ‘General information’ ‘Study information’ ‘Reporter information’ ‘Literature information’ into ARGUS SAFETY 01/29/17Katalyst Healthcares & Life Sciences 2
- 3. GENERAL SCREENGENERAL SCREEN 01/29/17Katalyst Healthcares & Life Sciences 3
- 4. GENERAL INFORMATION Report type: Spontaneous Report Clinical Trial Literature Case 01/29/17Katalyst Healthcares & Life Sciences 4
- 5. Reporter Type Indicates source of report. Only one report type per case. Used by ARGUS Safety workflow, expediting and PSUR generation. Case report type can change based on follow-up information 01/29/17Katalyst Healthcares & Life Sciences 5
- 6. GENERAL INFORMATION Data already entered during book-in: Country of incidence Initial receipt date Central receipt date Other fields: Case Status (shows work flow status) Fields referring to FU information (see chapter on FU) 01/29/17Katalyst Healthcares & Life Sciences 6
- 7. GENERAL INFORMATION Case Category: Important in searching Some case categories can only be used with certain report types (validation check) Assists in filtering cases 01/29/17Katalyst Healthcares & Life Sciences 7
- 8. CASE CATEGORY Spontaneous Report: Device spontaneous report Clinical Trial: Clinical trial Compassionate Use Device trial Epidemiological study Intensive monitoring project Non-Novartis trial Novartis patient registry Non-Novartis patient registry Other studies Post Marketing Surveillance Protocol exempted SAE 01/29/17Katalyst Healthcares & Life Sciences 8
- 9. CASE CATEGORY Other case categories: Beneficial effect unexpected Deactivated Case Deactivated Case – other MAH Lactation related Legal case Multiple patient case (used for legacy cases) Pregnancy prospectively received Pregnancy retrospectively received Pregnancy no AE Fwd to Tech OP 01/29/17Katalyst Healthcares & Life Sciences 9
- 10. Reporter Information: Reporter name and address must be collected if possible. Indicate in the narrative if the report is from a consumer, physician, health authority or other company. 01/29/17Katalyst Healthcares & Life Sciences 10
- 11. Reporter Information: Missing reporter last name: Do not leave ‘Last Name’ field empty but enter ‘Not available’ or ‘Anonymous’ The “Protect Confidentiality” checkbox must be checked for such cases This also applies to cases received from Health Authorities and other intermediary reporters, when the primary reporter’s name is not provided. 01/29/17Katalyst Healthcares & Life Sciences 11
- 12. Reporter Information ‘Health Care Professional’ field Select YES if the report was received from a health professional. from Health Authorities from scientific literature Qualifications of source are not identifiable Select No if report was received from Consumer Lawyer/attorney Other company Radio buttons are linked with ‘Reporter type 01/29/17Katalyst Healthcares & Life Sciences 12
- 13. Reporter Information Other reporter information fields: Reporter type (linked with HCP radio buttons and ‘Protect confidentiality’ tick box) Intermediary e.g. Regulatory Authority Customer response Pharmaceutical Company Medical Affairs Local Drug Safety Center Scientific Operations Sales Representative Technical Operations Report sent to Regulatory Authority by Reporter ? 01/29/17Katalyst Healthcares & Life Sciences 13
- 14. Reporter Information: ‘Protect Confidentiality’ tick box is checked for Consumer/patient reports or reports from relatives of consumer/patient Case where intermediary does not provide initial reporter’s name (anonymous reporter, HA reports, reports from other company) For all German and French cases For all correspondence contacts “Name and address withheld” will be printed on regulatory forms. 01/29/17Katalyst Healthcares & Life Sciences 14
- 15. Reporter Information: Primary reporter/correspondence contact Primary Reporter is the ACTUAL REPORTER e.g. patient, physician, pharmacist, etc. Primary Reporter will be printed on regulatory forms. A Primary Reporter can also be the Correspondence Contact. Correspondence Contacts not marked as Primary Reporter can be the patient’s physician name and address when provided by patient Health Authority, License partner or other intermediary correspondence address in literature reports. 01/29/17Katalyst Healthcares & Life Sciences 15
- 16. Guidance on primary in consumer cases was added: • AE is initially reported by a consumer, the consumer is entered as primary reporter. • When the case is later confirmed by a Healthcare Professional, the HP becomes the ‘Primary reporter’ and correspondence contact. • If the opposite occurs ie additional information is provided by the consumer after an initial report has been submitted by a HP, the HP remains the ‘Primary reporter’ and the correspondence contact. Reporter Information: 01/29/17Katalyst Healthcares & Life Sciences 16
- 17. Reporter Information: Specific scenarios Consumer is health professional Enter similar to consumer reports Select ‘Health Care Professional’ YES Check ‘Protect Confidentiality’ box 01/29/17Katalyst Healthcares & Life Sciences 17
- 18. Reporter Information: Specific scenarios… many more please refer to MAP 01/29/17Katalyst Healthcares & Life Sciences 18
- 19. Literature Reports: Entering the Literature Information If you select ‘Literature’ as a report type the following screen will be displayed: 01/29/17Katalyst Healthcares & Life Sciences 19
- 20. Pre-configured Studies SPECIFIC FIELDS AND PROCEDURESSPECIFIC FIELDS AND PROCEDURES 01/29/17 Katalyst Healthcares & Life Sciences 20
- 21. Pre-configured Study information Protocol ID - Populated from book-inProtocol ID - Populated from book-in Study ID - Populated from book-inStudy ID - Populated from book-in Centre ID - Study site - centres are configured for eachCentre ID - Study site - centres are configured for each specific study and can be selected from a drop down box.specific study and can be selected from a drop down box. In the product screen, depending on the trial design, the drug may have to be reselected from the administered drug field and the indication may have to be recoded. 01/29/17Katalyst Healthcares & Life Sciences 21
- 22. Case Categories:Case Categories: In addition to adverse event related case categories, for PMS/Registry cases, you have to select a specific case category - Post Marketing Surveillance - Novartis Patient Registry - Non-Novartis Patient Registry - Intensive Monitoring Project 01/29/17Katalyst Healthcares & Life Sciences 22
- 23. License Partner And other Company Specifics 01/29/17 Katalyst Healthcares & Life Sciences 23
- 24. License Partner Cases: Enter the initial reporter as a primary reporter. If the reporter is a health care professional or not specified, enter as a health care professional. If it has been stated that the reporter is not a HCP, enter as appropriate eg. Consumer, lawyer or relative. Enter the license partner as a second tab and mark as Correspondence Contact and tick Protect confidentiality The licence partner must be selected using the ‘Select’ button. If not configured, contact your local administrator. 01/29/17Katalyst Healthcares & Life Sciences 24
- 25. Cases from other companies Enter the initial reporter as a primary reporter If the reporter is a health care professional or is not specified enter as a HCP. If stated that the reporter is not a health care professional, enter as appropriate, eg. Consumer, lawyer or relative. Enter the Pharmaceutical company as a second tab and mark as Correspondence Contact and tick Protect confidentiality. Health Care Professional ‘No’ should be selected for the other company 01/29/17Katalyst Healthcares & Life Sciences 25
- 26. Thank YouThank You && QuestionsQuestions 01/29/17 26 Contact: Katalyst Healthcare’s & Life Sciences South Plainfield, NJ, USA 07080. E-Mail: info@KatalystHLS.comKatalyst Healthcares & Life Sciences
Editor's Notes
- #9: Clinical trial case category mainly used for Non Novartis studies, compassionate use and pregnancy.
- #12: If the investigator’s name and address is not recorded on the SAE, search to see if there are previous reports from the centre. Note on the case that the investigator’s name and address was taken from previous case. If there are no previous SAE’s, record the “last name” as “Not available” and request investigator’s full name and address.
- #13: Pharma Horsham clinical trials: All reports are from health care professionals.
- #14: For clinical trial cases, the reporter type is usually investigator (sometimes nurse). Both are health care professionals and the case will not save if the health care professional box is not ticked.
- #22: Other ID is not currently used by Pharma Horsham, but may be used to differentiate between different cohorts (groups of patients) in the same study. Be careful when entering week number reported, as it should refer to week of study not of calendar year.
- #23: Clinical trial case categories are mainly used for Non Novartis studies, compassionate use and pregnancy. Compassionate use cases, expanded access cases and Non-Novartis studies are all given dummy configurations. This helps with searching and retrievals therefore helping to eliminate duplicates.